NCT01994720

[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]

A Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events With Ticagrelor Compared to Aspirin (ASA) in Patients With Acute Ischaemic Stroke or TIA.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13,307 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg \[two 90 mg tablets\] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg \[three 100 mg tablets\] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction \[MI\], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).

Conditions

• Acute Ischaemic Stroke
• Transient Ischaemic Attack

Interventions

Type	Name	Description
DRUG	ticagrelor	ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.
DRUG	Acetylsalicylic acid (ASA)	ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.

Timeline

• Start date: 2014-01-07
• Primary completion: 2016-03-02
• Completion: 2016-03-02
• First posted: 2013-11-26
• Last updated: 2017-06-12
• Results posted: 2017-06-12

Locations

521 sites across 33 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Peru, Philippines, Poland, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, Vietnam